DDMAC's Internet Stance Could Increase Consumer Risk

[Pharma Newshound]

A new Competitive Enterprise Institute (CEI) analysis cautions that FDA’s current policy restricting use of Internet sponsored links could have the unintended effect of making regulated information less available to consumers and making less reliable and unsubstantiated information more available. The report (see attached pdf), issued just weeks before FDA holds a public meeting on drug advertising and promotion using the Internet and other new media, says that the agency’s crackdown on sponsored links and other Internet advertising by regulated companies “could elevate the prominence of search results that link to Web sites containing utterly unsubstantiated claims by fly-by-night operators for products that are largely beyond the agency’s enforcement reach. Indeed, if sponsored links for highly regulated drugs and devices become more rare, then an information seeker will be relegated to wading through a list of Web sites that contain all manner of information of dubious validity.”

The paper reviews objections that have been raised to FDA’s position that full risk information must be included on a Web page, banner ad, or sponsored link, rather than allowing use of Internet technology to place the risk information on a hyperlinked page. Defenders of this “one-click” approach say that the initial Internet ad is not the end but rather the starting point for an Internet user’s search for information.

Authors Arnold Friede (Arnold Friede & Associates) and CEI senior fellow Gregory Conko fault FDA for a 5/09 draft guidance on drug and device promotion generally that barely acknowledges the Internet’s existence other than in a footnote listing product Web sites among communication vehicles subject to regulation for advertising and promotion.

“The agency appears unwilling to recognize that hyperlinks are an integral part of the Internet with which virtually every Internet user is familiar,” they write. “Indeed, the very purpose of a key word search is to generate sponsored links to those sites where the searcher may find the relevant information he or she needs. This is precisely why a searcher initiates a key word search in the first place. To assert that the sponsored link’s landing page — on which the risk information is accessible — is irrelevant in determining the adequacy of the risk disclosure is to disregard the realities of the medium and to elevate form over substance.”

Friede and Conko also argue that FDA’s categorical rejection of the landing page as an integral component of the sponsored link could be seen as violating one of its own advertising interpretation principles — that seemingly separate statements should be aggregated and considered together in determining whether the ensuing ad complies with the risk disclosure requirements. Thus, FDA says that if reminder and help-seeking ads appear in close proximity, such as in the same magazine, they could be considered jointly as a promotional ad that requires full risk information disclosure. “It is not apparent why this same logic is inapplicable to hyperlinked risk disclosures in sponsored links where the information is accessible only one click away,” they say. “If the principle [is] that A accompanies B even if the two are not physically attached, then that same principle ought to apply in determining what constitutes a discrete component of an advertisement in the first place.”

See report attached.

[Arnie Friede]

Hey, John. This is America, after all, and everyone is entitled to their opinion—even you! For my part, the CEI paper was not offered or characterized as empirical evidence on any point. The language was carefully chosen to say that FDA’s policy “could have” the unintended effect postulated. The matter certainly deserves careful consideration and study. I would submit that your quick look at Google probably does not qualify as such an analysis. As for doing a disservice to FDA, I think that raising important arguments like these for consideration by everyone affirmatively serves FDA’s interests in having all of the arguments on all sides vetted. That is the essence of transparency.

As for characterization that what we have written is “Carefully Wrought BS”, both Greg and I are lawyers and, at least as to me, it is not the first time, nor will it likely be the last time, that someone has called what I have said “BS”. I am prepared to be judged on the merits of the analysis, including the analysis in CEI’s recent comments to FDA and the attached article of mine from FDLI Update titled, “Yes We Can: Time for an FDA Drug Advertising Policy”.

Thank you for raising this matter for discussion.

Arnie




ARNIE FRIEDE
ARNOLD I. FRIEDE & ASSOCIATES
Office: 212.585-0411 Cell: 917.514.9166
Arnie@FriedeFDALaw.com
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